Genencell Report Slashed from 17 Pages to 6, Omitting Unfavorable Findings

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An animal test evaluation report played a significant role in allowing Genencell, a drug development company implicated in allegations of illicit solicitation to the Ministry of Food and Drug Safety (MFDS) involving former Justice Minister nominee Kim Seung-won, to win approval for its clinical trial plan. The report, which was originally 17 pages long, was shrunk to just six pages when submitted to the MFDS. An SBS investigation found that key findings unfavorable to securing approval had been extensively deleted.

Reporter Son Hyeong-an reports.

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This is the final 17-page COVID-19 treatment evaluation report that Genencell founder Kang Se-chan received in August 2021 after commissioning animal testing from Jeonbuk National University.

Comparing this document with a draft obtained by SBS, observations that drug regurgitation and vomiting blood were noted in hamsters prior to autopsy, as well as a pivotal conclusion stating that "serious symptoms distinct from infection were observed," are missing.

Drug safety assessments that were unfavorable to the approval of the clinical trial plan were deleted at Genencell's request.

Furthermore, after the office of National Assembly Health and Welfare Committee Chair Lee Man-hee reviewed Genencell's treatment evaluation report submitted to the MFDS and compared it with the university's original report, it was confirmed that even more critical information regarding drug side effects had been removed.

Four photographs accompanied by the caption "observation of edema and hemorrhage in hamster lung tissue" were omitted from the submission to the MFDS, and the research team's comprehensive opinion was also expunged. The report, originally 17 pages, was drastically condensed to six pages and submitted to the MFDS on September 23, 2021.

Despite these circumstances, the MFDS approved the clinical trial plan in October 2021 based on the revised report submitted by Genencell.

[Lee Man-hee / Chair of the National Assembly Health and Welfare Committee (People Power Party): "In situations such as national disasters or high-risk clinical trials, I believe institutional mechanisms that guarantee the completeness of data are absolutely necessary."]

During today's (October 13) parliamentary audit of the MFDS by the National Assembly Health and Welfare Committee, criticism of the clinical trial plan approval process and demands for institutional reform are expected to mount.

(Video by Won Hyeong-hui | Graphics by Seo Seung-hyun | Materials provided by the Office of Rep. Lee Man-hee, People Power Party)
※ Please note: This article was translated by AI and may contain errors.